Automated method for analyzing samples

Patent metadata

Field	Value
Publication number	US-10711297-B2
Application number	US-201715675206-A
Country	US
Kind code	B2
Filing date	Aug 11, 2017
Priority date	Mar 14, 2013
Publication date	Jul 14, 2020
Grant date	Jul 14, 2020

Abstract

An automated method for analyzing a plurality of samples within a housing of a self-contained system. The system is loaded with a plurality of samples, after which a first assay is performed on a first sample subset and a second assay performed on a second sample subset. The two assays include exposing the samples to a target capture reagent having a solid support for directly or indirectly immobilizing a target nucleic acid that may be present in one or more of the samples. The two assays may be performed with the same or different target capture reagents and target nucleic acids, but the receptacles for performing the exposing step have substantially identical geometries. Following the exposing step, an amplification reaction for amplifying a region of the target nucleic acid is performed with each sample. The amplification reactions of the two assays are performed in receptacles having different geometries.

First claim

The invention claimed is:

1. An automated method for analyzing a plurality of samples, the method comprising performing within a housing of a self-contained system the steps of:
(a) loading the system with the plurality of samples;
(b) after step (a), performing a first assay on a first sample subset of the plurality of samples, the first assay comprising:
(i) exposing each sample of a first sample subset to a first target capture reagent comprising a solid support for directly or indirectly immobilizing a first target nucleic acid that may be present in one or more samples of the first sample subset; and
(ii) after step (b)(i), performing in each sample of the first sample subset a first amplification reaction for amplifying a region of the first target nucleic acid; and

(c) after step (a), performing a second assay on a second sample subset of the plurality of samples, the second assay comprising:
(i) exposing each sample of the second sample subset to a second target capture reagent comprising a solid support for directly or indirectly immobilizing a second target nucleic acid that may be present in one or more samples of the second sample subset; and
(ii) after step (c)(i), performing in each sample of the second sample subset a second amplification reaction for amplifying a region of the second target nucleic acid,

wherein for each sample of the first sample subset, step (b)(i) is performed in a first receptacle and step (b)(ii) is performed in a second receptacle, the first and second receptacles having different configurations, and
wherein for each sample of the second sample subset, steps (c)(i) and (c)(ii) are performed in a third receptacle, the first and third receptacles having the same configuration.

2. The automated method of claim 1 , wherein the first target capture reagent and the second target capture reagent are the same target capture reagent.

3. The automated method of claim 2 , wherein the solid support of the first and second target capture reagents is magnetically-responsive.

4. The automated method of claim 2 , wherein the first and second target capture reagents are obtained from a bulk reagent container in steps (b)(i) and (c)(i).

5. The automated method of claim 1 , wherein the samples of the first sample subset are different than the samples of the second sample subset.

6. The automated method of claim 1 , wherein the samples of the first sample subset are the same as the samples of the second sample subset.

7. The automated method of claim 1 , wherein the step of performing the first assay comprises reconstituting a lyophilized amplification reagent containing a polymerase for performing the first amplification reaction.

8. The automated method of claim 7 , wherein the amplification reagent further contains nucleoside triphosphates.

9. The automated method of claim 7 , wherein the amplification reagent is a unit dose reagent in an amount sufficient for performing a single first amplification reaction.

10. The automated method of claim 7 , wherein the amplification reagent is reconstituted in a well of a multi-well cartridge.

11. The automated method of claim 10 , further comprising the step of transferring the reconstituted amplification reagent from the well of the multi-well cartridge to the second receptacle with a robotic pipettor.

12. The automated method of claim 11 , wherein the first target capture reagent and the second target capture reagent are the same target capture reagent.

13. The automated method of claim 12 , wherein the first and second target capture reagents are obtained from a bulk reagent container in steps (b)(i) and (c)(i).

14. The automated method of claim 7 , wherein the step of performing the second assay does not comprise reconstituting a lyophilized amplification reagent containing a polymerase for performing the second amplification reaction.

15. The automated method of claim 14 , wherein the first target capture reagent and the second target capture reagent are the same target capture reagent.

16. The automated method of claim 15 , wherein the first and second target capture reagents are obtained from a bulk reagent container in steps (b)(i) and (c)(i).

17. The automated method of claim 1 , wherein the second receptacle is closed during the first amplification reaction, and wherein the third receptacle is open during the second amplification reaction.

18. The automated method of claim 17 , wherein the second receptacle is closed with a cap coupled thereto during the first amplification reaction.

19. The automated method of claim 1 , wherein the first amplification reaction includes temperature cycling.

20. The automated method of claim 19 , wherein the second amplification reaction is an isothermal reaction.

21. The automated method of claim 1 , wherein the first and second amplification reactions are different types of amplification reactions.

22. The automated method of claim 21 , wherein the step of performing the first assay comprises reconstituting a lyophilized amplification reagent containing a polymerase for performing the first amplification reaction.

23. The automated method of claim 22 , wherein the step of performing the second assay does not comprise reconstituting a lyophilized amplification reagent containing a polymerase for performing the second amplification reaction.

24. The automated method of claim 23 , wherein the first target capture reagent and the second target capture reagent are the same target capture reagent.

25. The automated method of claim 24 , wherein the first and second target capture reagents are obtained from a bulk reagent container in steps (b)(i) and (c)(i).

26. The automated method of claim 1 , wherein the third receptacle is a component of a multiple receptacle device, and wherein the second receptacle is not a component of a multiple receptacle device.

27. The automated method of claim 1 , wherein steps (c)(ii) and (b)(ii) are performed in first and second modules of the system, respectively, and wherein the first and second modules are at distinct locations of the system.

28. The automated method of claim 27 , wherein the first module is detachably coupled to the second module of the system.

29. The automated method of claim 27 , wherein steps (b)(i) and (c)(i) are performed in the first module of the system.

30. The automated method of claim 1 , wherein at least a portion of step (b)(ii) is performed simultaneously with at least a portion of step (c)(ii).

Assignees

• Gen Probe Inc

Inventors

• Buse David A
• Opalsky David
• Rhubottom Jason F
• Hagen Norbert D
• Tidd Jennifer L

Classifications

• B01L3/50825 Primary

  Closing or opening means, corks, bungs · CPC title

• B01L2200/0689

  Sealing · CPC title

• G01N35/04

  Details of the conveyor system {(G01N35/021 - G01N35/028 take precedence)} · CPC title

• B01L3/565

  Seals · CPC title

• B01L2200/026

  Fluid interfacing between devices or objects, e.g. connectors, inlet details · CPC title